Document 851rReRzLa82bj7z39q30eZ0d

TRADE SRPPITT AR226-3095 Study Title 100-PERSON HUMAN REPEATED INSULT PATCH TEST WTIH H-23046 (CONTROL),H-23004 (TEST), AND H-23045 (TEST) LABORATORY PROJECT ID: HLO-1998-01285 DATA REQTOREMENTS; AUTHOR; STUDY COMPLETED ON: PEEFORMING LABORATORY: David Gabriel April 17,1998 ConTox Ltd. For MEDICAL RESEARCH No. OR wosK REQUEST NO.: E. L Du Font de Nemours and Company EHlakstokenllRLoaabdo, rPa.tOor. yBfooxr T5o0xicology and Industrial Medicine Newarik, Delaware 19714-0050 ijmij Page 1 of 33 Company Sanitized. Does not contain TSCA CBj Material TestedHaskell Sample; Nn Svnonvms/r'nrfps Physical Form- Material Tested: HaskeU Sample No.Synonyms/Codes: Ph^ical^rm: Material Tested: Haskell Sample Nn Synonyms/Codes: GE3S1ERAL INFORMATTHM DuPont HLO 1998-01285 Control Material c-- 23046 cc--3 r3 Test Material C-- 23004 C--} ----i3 Tesllvlaterial c"TM il 23045 r---- -2- Company SaniiEzed. Does not contain TSCA CBS Physical FormSponsor: Study Initiated-Completed: DuPont HLO 1998-01285 E. L du Font de Nemours and Company Wilmington, Delaware January 5,1998 - See cover page Company Sanitized. Does not contain TSCA CBl DuPont HLO 1998-01285 DUPONT CENTRAL RESEARCH AND DEVELOPMENT HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE SUEMILETI CHAMBERS WORKS May 5, 1998 100-Person Human Patch Test with H-23046 fCoNTROL). H-23004 fTCST). AND H-2304J Attached is a report from ConTox Limited (Project No. 98-8412H). report are patch test methods, results, and conclusions. Included in the 23004 (TTheset pItuermpo),seanodf Hth-i2s3s0t4u5dy(Tweasst Ktoernd)etteormcaiunseetihreritpaotitoenntoiarl doeflaHy-e2d3c0o4n6ta(cCt ohnytproerlsIetenmsi)ti,vHity- in humans. 23004 During the induction and challenge phases of this study, H-23046 (Control Item), H- (Test Item) and H-23045 (Test Item) produced no adverse skin responses in 100%, 100%, and 100% respectively, of those subjects who were active participants. during bBoatshedtheupinodnutchtieoneffaencdtschoablsleenrvgeedphwaisthes,thneeittehsetr mHa-2te3r0ia4l6s (pClaocnetdrorleIpteemat)e,dHly-2o3n00th4e(Tseksint Item) or H-23045 (Test Item) are considered skin irritants nor sensitizing agents under the conditions that prevailed in this study. /\ Gregory S. Ladies, Ph.D. Research Toxicologist -4Company Sanitized. Does not contain TSCA f^t DuPont HLO-1998-01285 Prefect Nnmi^r- ConTox Limited P.O. Box 368, Fort Washington, Pennsylvania 19034-0368 Telephone: (215) 288-4882 Fax: (610)834-7221 98-8412H Testing Fap-ilHy- ConTox Limited 1358 East Lycoming Street Philadelphia, PA 19124 Sponsor^ E. I. du Pont de Nemours and Company Wilmington, Delaware Test Articles: Control Article: H-23004 H-23046 and H-23045 Test Articles Description: Control Article Description: Test Articles Received: 1 iHU f |^flw|H^H^ 1/2/98 Control Article Received: 1/2/98 Studv Initiated: Date of Report: 1/5/98 4/17/98 Study Completed: 2/11/98 Test: Object of Test: Reference: Modified DDraize Repeated Insult Patch Test Study in Human Volunteers To deterrmnini e the sensitizing properties of the test articles. The methnord employed in carrying out this test was similar to that de scribed in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" by J.H. Draize and published by the Association of Food and Drtrwurgr rO>ffwic--ialis- o-rf^th- e- ^UTn it e d' " States. Page 5 Company Sanitized. Does not contain TSCA CSt Project Number: 98-8412H DuPontHLO-1998-01285 E.I. du Font de Nemours & Company - H-23004, H-23045 and H-23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Method of Test: Test Panel: The test involved the application of the test article to the upper arms of a group of 111 volunteer panelists. The panelists ranged from 18 to 69 years of age (see Panelist List, Appendix HI). One hundred and six panelists completed the study. Prior to the initiation of the study, all panelists were in good general health and free of any visible skin disease or anomaly in the area to be patched. Each panelist was required to read, understand and sign an informed consent statement. Patch Preparation: The control fabric (H-23046) and the test fabric (H-23045) were tested as supplied. The test and control fabrics were- cut into ap proximately one inch square portions. A second test article (H-23004) was prepared as a 4:1 dilution in deionized water (20% w/w). An approximate 0.1 ml portion of test article was placed onto a 3/4" diameter Lintine disk (Filter Fabrics, Inc. Goshen, m. 46526), and all the test articles were placed onto a strip of 2" Dermicel hypoallergenic cloth tape (Johnson & Johnson, New Brunswick, NJ 08903). Before applying this strip, each portion of test material was secured m place with a gloved finger to insure proper application. This tape strip was then pressed into place on the upper left arm of each panelist at its designated test site. Induction Phase: These patches were applied to their designated contact sites and remained in place for 24 hours. At the end of this period, the patches were removed and the sites were examined for any dermal response. The panelists were then rested for a 24-hour period after which the skin sites were again ex amined. New patches were then applied to the same sites as previously used. The second applications were identical to the first and remained in place 24 hours. This procedure was repeated on Mondays, Wednesdays and Fridays until a series of nine applications had been made. Patch applications made on Friday were removed by the panelists on Saturday. The panelists examined the sites (with assistance if necessary) for any dermal response at the time of re moval and again at 48 hours and reported their observations prior to the next application. The same sites were used throughout the study. In the event when one induction application was missed, the panelist was al lowed to make it up at the end of the induction patch period. These patches were applied on Monday following the last scheduled (ninth) induction appli cation on Friday. Challenge Phase: After the 9th application, a rest period of approximately 2 weeks elapsed after which a challenge application was applied in the same manner and to the same sites described above. A duplicate challenge applica tion was also applied in the same manner to a virgin site (previously untreated) on the other arm. The challenge applications were removed after 24 hours and the sites were examined and graded for signs of irritation or sensitization. -6- ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368 Company Sanitized. Does not contain TSCA CBI Project Number: 98-8412H DuPontHLO-1998-01285 E.I. du Font de Nemours & Company - H-23004, H-23045 and H-23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Method of Test: (continued) A follow-up examination was conducted at 48 hours after the challenge appli cations (24 hours after patch removal). The grading scale used throughout both the induction and challenge phases is shown in Appendix IV. Results: Results obtained with the control article (H-23046) are presented in Appendix I. Individual panelist data for the control article are presented in Table 1. A summary of the data for the control article is presented in Table 2. Results obtained with the test articles (H-23004, H-23045) are presented in Appendix n. Individual panelist data for the test articles are presented in Tables 1 and 3. A summary of the data for the test articles is presented in Tables 2 and 4. Conclusion: From the results obtained with this test panel, the test and control articles do not appear to be primary skin irritants. The test and control articles do not ap pear to be fatiguing agents. The test and control articles do not appear to be sensitizing agents under the study conditions utilized. Signatures: Submitted by ConTox Limited: ^ J ^ U ^ / m Freed^eerricickkUrbach, M.D. C'o/v*n-*sc'u*'iillt+a<inf+t DT^eotr^mvi*aa+t/o^1l/o^ngrtics''ft' / yXy/t^L^JC ^Ut^V^M^S^ RaymondMark, M.D. Study Director/Consultant Approved by: ^o?'.-A^l_ A. Karl L. Gabriel, V.M.D, Ph.D. President y//<^7 7 Date / ' / Date^ / ^ - Y//7/fr Date7 - 7 - ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368 ComparySanllTzed-. Does not contain TSCA CW Project Number: 98-8412H DuPontHLO-1998-01285 APPENDIX I RESULTS FOR CONTROL ARTICLE -8- ConToK Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368 Company Sanitized. Does not contain TSCA CBB Project Number: 98-8412H Control Article: 23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix Table 1 - Individual Panelist Data Challen gi ^ S 3" 1 o b i ^j a00\ y 0 a ' nff 3' ^3 S 1 0 " HTS s"o OS 0 ^ Ss UJ 3. ^ ^ . Bo f* N' 0 a a 0 (B y> 3 & 8 3 " 2. 3 -1 GS 0 > 0 es )wivcti<MLEhase Oris;inal Paneli;st Numbier 1 000000 500607008 2 0 3 000000 000000 4 000000 000000 5 000000 000000 6 000000 000000 7 000000 000000 8 000000 000000 9 000000 000000 10 000000 000000 11 000000 000000 12 000000 000000 13 000000 000000 14 000000 000000 15 000000 000000 16 000000 17 000000 000000 18 000000 000000 19 000000 000000 20 000000 000000 21 000000 000000 22 000000 000000 23 000000 000000 24 000000 25 1 2448 0 0 2 2448 .0 0 3 2422 00 000000000000 000000000000 24 = Reading 24 hours after application. 4 [ J 9 t 10** 24 48 2472 2448 24 24--22 24 4& 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 00 0 0 0 0 0 0 0 0 0 0 - = Missed reading. Si te 24 -4S 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 48 = Reading 48 hours after application. D = Discontinued from the study for personal reasons. 72 = Reading 72 hours after application. W = Not graded. Next patch applied. * = Panelist missed the scheduled patch appliesition f<irpcisonal reasons. Panelist was patched 01itht;next scheduled1application day, and the patch series extended until 9 induction applications were applied. ** = Make-up patch application. ConToil Limited - P.O. Box 368, Fon Washington, Pennsylvania 19034-0368 Project Number: 98-8412H Control Article: 23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix Table 1 - Individual Panelist Data Challen o S g r- 1 "0 b ? S UJ s i^ 1 a' "a o 1 1 i I. I z wt 8 CT -^ M s 5. o' fe> 00 R" (0 a 0 (a (A 3 Qpry. CT 1 (a 3 -(! 0 P0 SB In<iluctionPhase Orig;inal Panellst Numbiss. 26 000000 0500607008 27 0 28 000000 0000000 29 000000 0000000 30 000000 0000000 31 000000 0000000 32 000000 0000000 33 000000 000000- 34 000000 000000 35 000000 000000- 36 000000 0000000 37 000000 0000000 38 000000 0000000 39 000000 0000000 40 000000 0000000 41 000000 0000000 42 000000 0000000 43 000000 0000000 44 000000 0000000 45 000000 0000000 46 0000000 47 000000 0000000 48 000000 0000000 49 000000 0000000 50 1 2 M4S 2448 00 00 0000 3 2422 00 00 0 0 0 0 0 0 0 0 0 0 0 0 0 24 = Reading 24 hours after application. 4 2448 2422 244S 24 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 - 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0000 0 0 0 0 0 0 0 - * 9 K)** 4S 24 -Z2 24 4S 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 a 0 0 0 0 0 0 0 0 0 0 - = Missed reading. Site 24--4S 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 48 = Reading 48 hours after application. D = Discontinued from the study for personal reasons. 72 = Reading 72 hours after application. (a) = Not graded. Next patch applied. * = Panelist missed the scheduled patch.appliesition ft>r personal reasons. Panelist was patched on the next scheduled application day, and the patch series extended until 9 a .duction applications were applied. ** = Make-up patch application. ConTox Limited - P.O. Box 3(8, Fort Washington. Pennsylvania19034-0368  1 ffl 3 < cfl S & 0 > 0 ca Project Number: 98-8412H Control Article: 23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix Table 1 - Individual Panelist Data Challe ]Panelist ISTumber 51 52 53 54 1 8 55 56 E: 57 3B"' 58 s. 59 "0 60 0 oa 61 62 i^ 0^ 63 00 l^-a 64 - 65 >-- 66 ^ 67 '51 68 i^! 69 70 71 1 72 73 ,,'o. S 74 t^ 75 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 24 -IS 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 24--Z2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 In<lufitifliLEha?e 4 5 6 24--4S 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 24--4S 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 24--22 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 r 24--4S 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 .0 S } 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 S 1 24--Z2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 10** Original Site 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D 0 0 0 0 24 = 48 = 72 = * = ** = Reading 24 hours after application. - = Missed reading. Reading 48 hours after application. Reading 72 hours after application, D = Discontinued from the study for personal reasons. (a) = Not graded. Next patch applied. Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled day, and the patch series extended until 9 induction applications were applied. Make-up patch application. application ConTox Umted - P.O. Box 368, Pon Washington.Pennsylvania 19034-0368 Project Number: 98-8412H Control Article: 23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix I Table 1 -Individual Panelist Data Challen 0 o a g ^ SB ^53 ' a a Q R Ui 1 0 0 3. 0>. 5" -(fIf 0 ?> 0 ea Panelis t Numbe !T 76 000000 500607008 77 0 78 000000000000000000 000000000000000000 |p 79 80 0 f< 81 000000000000 000000000000 C3 82 ' 83 000000 000000 &. 84 000000 000000 -a b 85 000000000000 000000000000 1 86 ?s 000000 00000 UJ 87 (^ 00 88 000000 00000- ' 89 000000000000 000000 Sf R90 000000 ' 91 000000 000000 109 92 000000 5 93 0000 000000 s 94 000000 000000 CO 95 000000 000000000000 1>< 96 s. 97 000000 000000 ^ 'o 98 000000 000000 S 99 0000000000 000000000000 s. 100 000000 000000 oo 1 2448 00 0 0 2 24AS 0. 0 0 0 3 2422 00 0 - 0.0 00 M ten)n Phase 4 J 24- 48 2422 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 * a 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 244S 24;108 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 9 24--Z2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 K )** 24-- 4S 0 0 Ori,ginal S ite 24- 4S 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 24 = Reading 24 hours after application. - = Missed reading. 48 = 72 * = ** = Reading 48 hours after application. D = Discontinued from the study for personal reasons. Reading 72 hours after application. (a) = Not graded. Next patch applied. Panelist missed the scheduled patch application for peirsonal reasons. Panelist was patched 01tithfinext scheduled a pplication day, and the patch series extended until 9 induction applications were applied. Make-up patch application. ConTox Limiled P.O. Box 368, Foti Washington, Pennsylvania 19034-0368 Project Number: 98-8412H Control Article: 23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Panelist Number 101 102 103 104 i 105 106 r. 107 s 108 Q. 109 'XI 0 110 tB 111 s U) 1 M J& 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D 0 0 0 0 2 24 M 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D 0 0 0 0 Table 1 - Individual Panelist Data 3 21 JZ2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D 0 0 0 0 Induction Phase 4 5 6 0 0 24 32 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D D D D D D D D D 0 0 0 0 0 0 0 0 0 0 0 0 7 24, 48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D 0 0 0 0 8 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D 0 0 0 0 9 2A .22 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D 0 0 0 0 10** 2448 Appendix Challen Oiriginal Site 24 48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D 0 0 0 0 gs 1.24 548 72 S* OS Reading 24 hours after application. - = Missed reading. Reading 48 hours after application. D = Discontinued from the study for personal Reading 72 hours after application, (a) = Not graded. Next patch applied. reasons. Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled day, and the patch series extended until 9 induction applications were applied. Make-up patch application. applicat:iion ConTM Limited -.P.O. Box 368, Fort Wellington, Pennsylvania 19034^1368 Appendix fi^ 0 a ia 5 0) fa 3P^.J N" (B p" a 0 o U) 3 & 0 0 3. S3'. ^ ta 0 > 0 (33 Moaiiieia uraize Kepeatea insult ratcn lest a tudy irtjrtum;anV olunteers Total Panelists; 1 24AS 111 111 2 244S 111 111 3 2422 111 111 Tilhie 2.-SurnmarvofData In<luctiian Phase 4 111 111 5 6 7 8 24- 111 111 111 111 111 111 111 111 S i 24 -22 111 111 K3** 24 1S 2 2 C tiaUs (3rig;inal Si te 2a--4S 1 11 111 Grade ? i 0 108 109 109 109 109 108 102 107 10?!108 108108 107 107 102 107 108 108 2 2 106 106 ^ 000000 000000 1+ 'T3 000000 000000 0 2+ CO 000000 000000 3+ 1^1 o00\ 000000 000000 31 . 4+ 000000 000000 I?i k 0" 000115 5' * 000000 000001 T) (a) 000000 000000 i D 222222 333333 CO 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 .0 0 0 1 5 0 0 1 0 0 0 1 0 3 3 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 3 3 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 5 t-- \o 0 UJ 4& s 1T\ 00 24 = Reading 24 hours after application. . = Missed reading. 48 = Reading 48 hours after application. D = Discontinued from the study for personal reasons. 72 = Reading 72 hours after application. (a) = Not graded. Next patch applied. )(s -- Panelist missed the scheduled patch iipplication fiirpe:rsonal reasons. Panelist was patched <anth(snext schedijledapplication day, and the patch series extended until 9 induction applications were applied. ** = Make-up patch application. ConTox Limited - P.O. Box 36B, Fon Washington, Pennsylvania I9034-036B Project Number: 98-8412H DuPontHLO-1998-01285 APPENDIX H RESULTS FOR TEST ARTICLES - 1 5 - ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368 Company Samt5zed. Ooes net contain TSCA CBI Project Number: 98-8412H Test Article: 23004 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix Table 1 - Individual Panelist Data Challen --IS InducitionPhiise Panelist 1 Number 2 3 4 5 6 7 0:riginal 8 9 10** Site 24 --Z2 21 4i1 24 48 24--22 24. 48 21 21 Z2 M 48 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8 "Q 9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 o 10 11 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 u <3\ 12 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 i 13 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 ^14 ch 15 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 s ' 16 0 0 0 6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 17 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 i 18 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 19 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 *. 20 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 21 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 I 5' 22 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 CO ys s 23 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 fc 24 s 0- 25 1 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 a. a 24 = Reading 24 hours after application. s 48 = Reading 48 hours after application. = Missed reading. D 7ii2. -= Rmeeaadniningg7/^2 hnours afnter application. = Discontinued from the study for personal reasons. (a) = Not graded. Next patch applied. * = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application day, and the patch series extended until 9 induction applications were applied. ** = Make-up patch application. 3 'JS ConTox Limited P.O. Box 368, Fort Washington,Pennsylvania 19034-0368 0 > 0 ra Project Number: 98-8412H Test Article: 23004 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix I Table 1 - Individual Panelist Data Challeng lmiu<?tio' n Phase Orig;inal Paneliiit 1 4 9 K )** Numbia 2448. 2448, 2422 21--48. 48 2422 2448. 24 .48 24- Z2 24 48, 2 3 26 0 0 0 0 0 0 000000 500607008 27 0 0 0 0 0 0 0 28 0 0 0 0 0 0 000000000000 000000 Q 29 000000 % 30 000000 000000 0 x 31 000000 000000 r1 ' 32 000000 000000 1 33 000000000000 0000000000- -0 34 0 35 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 00000 S? 36 0 0 0 0 0 0 000000 000000 GJ 37 000000 000000 CT\ 00 38 000000 000000 39 000000 000000 ! 40 000000 000000 r^ 41 000000000000000000000000 000000000000000000000000 1 15' % 42 0 0 !3 43 44 fi> 45 000000 000000 5 ' 46 000000 s 3' 47 0 0 0 0 0 0 - 0 0 - 0 0 - 0 0 0 0 0 0 0 0 0 0 0 00 00 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000000000 000000 !3i 000000 8 48 0 0. 0 0 0 0 0 0 0 0 0 - * a 0 0 0 0 1 00 g 49 0 0 0 0 0 0 Q. S 50 0 0 0 0 0 0 000000 000000 c^ a 00 000000 000000 Q G> 24 = Reading 24 hours after application. - = Missed reading. W 3 48 = Reading 48 hours after application. D = Discontinued from the study for personal reasons. Si te 24 -AS 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2. 72 - Reading 72 hours after application. (a) = Not graded. Next patch applied. 0 0 * = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application 3 "a* day, and the patch series extended until 9 induction applications were applied. B 3" ** = Make-up patch application. "4 01 5 ConTox United - P.O. Ben 368, Fort Washington, Pennsylvania 19034068 > 0 ra ProjectNumber: 98-8412H Test Article: 23004 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix II Table 1 - Individual Panelist Data Challeng Paneliist 1 In<iucti on Phase 4 [ Orijpnal 9 10** S ite Numbi 2 3 51 24 48 2422 2448. 24 24 Z2 24 48 24 -AS 0 0 0 0 0 0 0 0 000000 500607008 52 0 0 0 0 0 0 0 0 0 53 0 0 0 0 0 0 0 0 000000 000000 n 54 0 0 0 0 0 0 0 0 000000 000000 S3, 55 000000 000000 S 56 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 000000 000000 57 000000 000000 1 58 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 000000 ,, 59 000000 000000 o 60 - - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 000000 S? 61 0 0 0 0 0 0 00000 000-00 62 000000 000000 000\ 63 000000 | 64 00 00 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 000000 SSSS65 000000 000000 00 00 00 1 66 000000 000000 00 00 0 5' <;T w 0/ 68 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 000000 a sa 000000 000000 S |1 69 70 0 0 0 0 00 0 0 0 0 0 0 0 0 0 0 0 0 000000 W 000000 000000 U 71 000000 000000 1 3. 72 A* 000000 N 73 0 000000 00 <Qo. ^ 74 000000 1 0 75 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D D D D D D D D D 0 0 0 0 0 0 0 0 0 0 0 0 000000 0 00 000000 000000 (D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D 0 0 0 0 w 24 = Reading 24 hours after application. - = Missed reading. 3 2. 48 = Reading 48 hours after application. D = Discontinued from the study for pe;rsoniilreas ons. 0u 72 = Reading 72 hours after application. (a) == Not graded. Next patch applied. a, * = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next schedulec1application %3 , day, and the patch series extended until 9 induction applications were applied. -i ** = Make-up patch application. 0) 0 > ConTox Limited P.O. Box 368, Port Washington, Pennsylvania19034-0368 0 S3 Project Number: 98-8412H Test Article: 23004 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix II Table 1 - Individual Panelist Data Challeng In'ilucti on Phase Orij^inal Paneliiit 1 4 9 1 10** Numbe3: 2448. 2448 2422 24 -48 24- 48 2412 2448 24 24- Z2 24- 48 2 3 76 0 0 0 0 0 0 000000 500607008 77 0 0 0 0 0 0 0 78 000000 000000 S' 79 00 00 00 0 0 0 0 0 0 0 0 0 0 0 0 000000 80 000000 000000 81 000000000000 000000000000 0 0 0 0 0 0 0 0 0 0 0 0 S ite 24 0 0 0 0 0 0 0 0 0 0 0 0 lI. " 82 0 0 0 1 83 0 0 0 000000 000000 , 84 0 0 0 000000 000000 P 85 0 0 0 000000000000 000000000000 1 86 ^ 87 000000 00000- -^ 88 0 0 0 0 0 0 0 0 0 000000000000000000 00000000000000000- IS ' 89 fst-S^\o, 90 ' 91 0 0 0" 0 0 0 000000 000000000000 - 1 92 B 3 93 00000- 000000 1 s? 94 000000 000000 1 | 95 0000000000 000000000000 1 W& 96 00 000000 000000 5- 97 0000000000 000000 5isi S 98 ^ 99 00 000000 0. 100 000000 000000 a '00 000000 000000 a 0 M 24 = Reading 24 hours after application. 0 0 0 0 0 0 * a - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - = Missed reading. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 48 = Reading 48 hours after application. a 72 = Reading 72 hours after application. 0 D = Discontinued from the study for personal reasons. (a) = Not graded. Next patch applied. 0 * = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application gr day, and the patch series extended until 9 induction applications were applied. ** == Make-up patch application. -< eig 0 ConTox Limited -P.O. Box 368, Fort Washington* Pcnnsyivarua 19034-0368 0 a Project Number: 98-8412H Test Article: 23004 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix I 1 o v 1 V) sa v N" 0 pb . 0 (i> u> "i , 0 0 g. B) ;3" -ini 0 > 0 S3 Table 1 - Individual Panelist Data Challeng In<?wton Phase Paneli st I 2 3 4 9 1 10** Numbia 2448, 2448, 2422 24 48 48 2422 2448. 24 -4S -Z2 2i448 101 0 0 0 0 0 0 000000 500607008 102 0 0 0 0 0 0 0 103 0 0 0 0 0 0 000000 000000 g 104 0 0 0 0 0 0 000000000000 000000000000 ^ 105 0 0 0 0 0 0 000000 000000 ^ 106 0 0 0 0 0 0 ' 107 0 0 0 0 0 0 000000 000000 I 108 D D D D D D D D D D D D D D D D D D 000000 000000 ,, 109 D D D D D D D D D D D D D D D D D D 000000000000 000000000000 o 110 1 1" UJ Ot 00 0 0 0 0 0 0 0 0 0 0 0 0 S , a M % 0 101 0 % 5" Orig;inal Si te 24 -4S 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D 0 0 0 0 "d 5 ^ < 5 5- 24 = Reading 24 hours after application. - = Missed reading. 48 = Reading 48 hours after application. D = Discontinued from the study for personal reasons. g 72 = Reading 72 hours after application. (a) = Not graded. Next patch applied. Ch "" Panelist missed the scheduled patch;ippliisation ft>rpeirsonal reasons. Panelist was patched c>nth(;next schedulied application 00 day, and the patch series extended until 9 induction ap]plications were applied. ** == Make-up patch application. * ConTox Limited - P.O. Box 368, Fort Washington. Pennsylvania 19034-0368 Project 1lumber: 98-8412H Test Articie: 23004 Modifieid Draize Repeated Insult Patch Test SItudy in Humian Volunteers Appe:ndixll Total Panelisi& 1 244S 111 111 2 3 244S 111 111 2472 111 111 Table 2 - Summary of Data In<luction Phase 4 244S 111 111 5 6 7 8 244S 111 111 2472 111 111 244S 111 111 244S 111 111 9 i 24- Z2 111 111 H0** 24--48 2 2 CIiialism Orig;inal Si te 24 -IS 111 111 Q Grade 1 0 108 109 109 109 109 108 102 107 108108 108108 107 107 102 107 108 108 2 2 106 106 c^ 000000000000000000000000000000 0000000000000000000000000000000000000000 3 010000000010 00001150 5 00000010 1 222222 0303030303030313 1IS? 01 1 0. ^ 1+ b g) 2+ ?< i 3+ " 1^ ^ 1-- 8 , - sr . * 3? / ^ S D s' Iri 00 00 0. 0 0 0 0 0 0 0 0 0 0 0 5 0 1 0 0 1 3 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 5 Q. ^24 = Reading 24 hours after application. - = Missed reading. a a %48 = Reading 48 hours after application. D = Discontinued from the study for person:rireas ons. 0 u 72 = Reading 72 hours after application. (a) = Not graded. Next patch applied. a a * = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application 0 day, and the patch series extended until 9 induction applications were applied. p ** = Make-up patch application. ?" 9. s -i ConTox Limited - P.O. Box 368, Fort Washington, Pamsylvmia 19034-0368 OT 0 > 0 Project Number: 98-8412H Test Artide:23045 Modifieid Draize Repeated Insult Patch Test Studyin Huirian\'blunteers Appfsndix II TahlIe 3-In'dividual Panelist Data CSalienti Paneli st 1 In<iwti on Phase 4 Orii^inal 9 10** S ite Numba 2448, 2448. 2422 2 3 1 0 24 4S 2422 244S 24 -4S 24 Z2 24 4S 0 0 0 0 0 24--4S 0 0 000000 500607008 2 0 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 000000 000000 Q 4 000000 000000 Si 5 000000 000000 . 6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 . 0 0 0 0 000000000000 000000000000 1. 7 | 8 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 000000 ^ 9 0 0 0 0 0 0 0 0 000000 000000 P 10 000000 000000 ' 11 0 0 0 0 0 0 0 00 00 0 0 0 0 0 0 0 0 0 0 0 000000 ^ 12 000000 000000 ^ 13 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000000000 000000000000 a ',14 000000 000000 |Kl5 1 ' 16 000000 000000 00 0-0 00 t I7 000000 ? 3 18 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000000000000000 000000000000000000 00 00 00 1 19 | 20 000000 | 21 vs 5- 22 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 000000 3 23 0000000000 000000 00 NCO U'?J 24 000000 Q. S 25 000000 000000 01 '-' 0 0 a 00 000000 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 dw 24 = Reading 24 hours after application. - = Missed reading. 3 48 = Reading 48 hours after application. D = Discontinued from the study for personal reasons. a 72 = Reading 72 hours after application. (a) = Not graded. Next patch applied. 8 * = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application 3a?, day, and the patch series extended until 9 induction applications were applied. 5" ** = Make-up patch application. -ie 0 ConTox Limited P.O. Box 368, Fort Washington, Pennsylvania19034-0368 > 0 ^ Project Number: 98-8412H Test Article: 23045 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix I Table3 - Individual Panelist Data Challeng gi i x r3 . S & fl 0 ca S w a\ 1s51 M w S- ' 0 H 1 i 2 " 1 1. < | W 5. $fl 83. 5 rSSf" 0 u ^ a S " 0 0\ 0 0 W 3 0 p< 0 0 13 5 -1 0 > 0 S3 In.duction Phase (3rig;inal Paneli st 1 A \ 9 10** Number 2448 2448 2422 24 4S 244S 2422 2448 24 -4S ,24 72 244S 2 3 26 0 0 0 0 0 000000 0500600708 27 0 0 0 0 0 0 28 0 0 0 0 0 000000 0000000 29 0 0 0 0 0 000000 0000000 30 0 0 0 0 0 000000 0000000 31 0 0 0 0 0 000000 0000000 32 0 0 0 0 0 000000 0000000 33 0 0 0 0 0 000000 000000 34 0 0 0 0 0 000000 000000 35 0 0 0 0 0 000000 000000 36 0 0 0 0 0 000000 0000000 37 0 0 0 0 0 000000 0000000 38 0 0 0 0 0 000000000000 00000000000000 In9 40 - 0 - 0 0 0 0 0 0 0 000000 0000000 41 - 0 0 0 0 000000 0000000 42 0 0 0 0 0 000000 0000000 43 0 0 0 0 0 000000 0000000 44 000000 0000000 45 00 00 00 0 0 0 0 0 0 0 0 0 0 0000000 46 0 0 0 0 0 000000 0000000 47 0 0 0 0 0 000000000000 00000000000000 0000 00 0000 000 48 0 0 0 - * a 0 49 0 0 0 0 0 50 0 0 0 0 0 000000000000 00000000000000 24 = Reading 24 hours after application. - = Missed reading. Si te 2S4 -4S 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 48 = Reading 48 hours after application. D = Discontinued from the study for personal reasons. 72 " Reading 72 hours after application. (a) = Not graded. Next patch applied. * = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application day, and the patch series extended until 9 induction applications were applied. ** = Make-up patch application. ConTox United - P.O. Box 368, Fort Washington, Pennsylvania190344368 g 3 B 5t3 ^ a 1' a a g s & 8 1 3- -1 (ft 0 > 0 Project Number: 98-8412H Test Article: 23045 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix II Table 3 - Individual Panelist Data Challeng Indiwtion Phase Oriiginal Paneli st Numb er 7 8 51 52 000000 53 000000 000000 g 54 000000 000000 5 55 000000000000 000000 ?. 56 000000 57 000000 000000 I 58 000000 000000 ^ 59 000000 000000 P 60 00000000000 000000 1 61 000-00 V; 62 000000 000000 ^ 63 000000000000 000000000000 S^64 sg .^65 000000000000 000000 1 ' 66 000000 1 67 000000 000000 X 68 000000000000 000000 1 69 000000 | 70 000000 000000000000 I^<* 71 72 000000 000000 73 0000000000 000000 g 74 1 75 1 2448, 00 - 0 0 2 2448. 00 0 0 3 2422 00 00 00 000000000000 000000000000 24 = Reading 24 hours after application. 4 5 6 48. :24 4S 2422 244S 24 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D D D D D D 0 0 0 0 0 0 - = Missed reading. 9 10** 24 Z2 24 48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D 0 0 0 0 0 0 S ite 24.--4S 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D 0 0 0 0 48 = Reading 48 hours after application. D = Discontinued from the study for personal reasons. 72 = Reading 72 hours after application. (a) = Not graded. Next patch applied. Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application day, and the patch series extended until 9 induction applications were applied. Make-up patch application. ConTox Limited - P.O. Box 368, Fort Washington. Pennsylvania 19034-0368  3 "g 3S5 W . ^ & 0 " a 0 0 3. 25 . "1 K> 0 > 0 Project Number: 98-8412H Test Article: 23045 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix II Table 3 - Individual Panelist Data Challeng Jnducti on Phase (3rig;inal Paneli st 1 2 3 tt. 9 i 10** Numbi 76 24--48 48 2422 2448 24 2A- 72 2448 0 0 0 0 0 0 000000 500607008 77 0 0 0 0 0 0 0 78 0 0 0 0 0 0 000000000000 000000000000 Q 79 s) 80 0 0 0 0 0 0 0 0 0 0 0 0 000000000000 000000000000 i. si 82 000000 000000 g 83 000000 000000 , 84 000000 000000 o 85 000000 000000 g' 86 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 000000 > 87 000000 00000- Os 88 000000 00000- g -89 000000 000000 1^90 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 000000 ' 91 000000 000000 1 "2 000000 93 0000 000000 000 94 000000 |1 95 000000 000000 t 96 000000 !-! 97 00 00 0" 0 0 - 0 0 0 * a 0 0 00 0 0 0 - 0 0 0 0 0 00 00 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000000000 000000000000 98 S 99 000000 S 100 000000 000000 s 0 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0. 0 0 0 0 0 0 0 0 0 0 24 = Reading 24 hours after application. - = Missed reading. Site 2A--48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 48 = Reading 48 hours after application. D = Discontinued from the study for personal reasons. 72 = Reading 72 hours after application. (a) = Not graded. Next patch applied. * = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application day, and the patch series extended until 9 induction applications were applied. ** = Make-up patch application. CoiiTox Limited - P.O. Box 366, Fort Washington,Penasylvwia 19034-0368 Project Number: 98-8412H Test Article: 23045 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 3 - Individual Panelist Data In<i w c t i o n P h a , ?e Panelist 1 2 3 4 5 6 7 S 9 10** Number 2A -IS 24 -48 24 Z2 24 101 0 0 0 0 0 0 0 4S 24 -48 24- Z2 24 -45 24 -4S 2244_22 24_4S 0 0 0 0 0 0 0 0 0 0 0 102 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 103 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 g) 104 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 ^ 105 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 S 106 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 t- 107 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 s 108 D D D D D D D D D D D D D D D D D D & n 109 D D D D D D D D D D D D D D D D D D P 110 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 03 S 111 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Appendix II Challeng Orig;inal - Site 24 1S 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D 0 0 0 0 gIs) 0\ i 24 Reading 24 hours after application. - = Missed reading. 48 Reading 48 hours after application. D = Discontinued from the study for personal reasons. 72 Reading 72 hours after application, (a) = Not graded. Next patch applied. * Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application day, and the patch series extended until 9 induction applications were applied. ** Make-up patch application. CmiTon Limited - P.O. Box 368, Tort Wiishington, PBinsyhimla 19034-0368 Projject Number: 98-8412H Tes tArtide: 23045 Moidifieid Draize Repeated Insult Patch Test SItudy iia Hunian Volunteers Appeindix II TiMe 4 - Summary of Data f hallens; 1 3^otal[ Eaifilifits; ill ill 2 ill ill 3 ill ill In'duction Phase 4 24 4S 111 111 5 6 7 8 111 111 111 111 111 111 111 Ill 9 l 24 -Z2 111 111 H0** 24 -4S 2 2 Or4final Siite 24 -48 111 111 9 iradi V. i? 0 108 109 109 109 109 108 102 107 108108 108108 107 107 102 107 108 108 2 2 106 106 g 1 000000 0000000 1+ 'V 0 000000 0000000 2+ a 000000 0000000 t^ cr\ 3+ 00 000000 0000000 4+ 1-) 000000 0000000 <! >-l 1 5 0000115 * 10 0-0 01 0 0 0 0 0 0 0 0 0 0 5 0 1 0 000000 000000 B (a) 0 1 000000 0000000 D 3 3 (1 222222 3333333 5' 33 t 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 3 3 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 5 |;<B . = Reading. 24 hours after application. W s: Reading 48 hours after application. - = Missed reading. D = Discontinued from the study for piarson;ilreas ons. . 72 = Reading 72 hours after application. (a) = Not graded. Next patch applied. 0 * = Panelist missed the scheduled patch application f<ar personal reasons. Panelist was patched ionth<snext schedijleda.ppliciation J d a y , and the patch series extended until 9 inducticin applications were applied. ** = Make-up patch application. 3 0 w 0 ConTox Limited P.O. Box 368. Foil Washington, Pennsylvania 19034-0368 0 5 S5', -tl 0 0 Project Number: 98-8412H DuPontHLO-1998-01285 APPENDIX in PANELIST LIST - 2 8 - ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368 Company Sanitized. Does not contain TSCA CBI Project Number: 98-8412H E.I. du Pont de Nemours & Company Modified Draize Repeated Insult Patch Test Study in Human Volunteers DuPont HLO-1998-01285 Appendix III Panelist # 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 Initials R.H. S.D. W.C. J.M. M.R, E.K. K.K. T.R. J.L. W.M. L.S. E.S. B.R. D.P. E.T. J.H. V.F. B.C. A.M. I.M. B.M. A.S. M.T. L.H. C.W. C.W. S.A. B.B. N.B. J.B. C.O. L.W. L.M. J.S. T.T. S.D. J.W. M.G. M.S. R.S. C.L. M.B. M.B. L.D. P.A. Ag e 45 30 47 48 36 38 27 54 41 31 51 49 32 26 42 38 50 29 35 31 24 32 34 50 29 42 37 42 46 29 45 34 31 31 33 35 47 50 41 49 57 33 57 34 36 Panelist List Occupation Homemaker Waitress Laborer Meat Wrapper Homemaker Homemaker Cement Worker Bartender Secretary Waitress Printer Laborer Secretary Hairdresser Dental Assistant Homemaker Welder Laborer Unemployed Homecare Nurse Homemaker Baker Meatpacker Waitress Hostess Homemaker Homemaker Homemaker Homemaker Insurance Adjuster Homemaker Homemaker Homecare Nurse Homemaker Homemaker Homemaker Painter Homemaker Homemaker Laborer Homemaker Homemaker Homemaker Homemaker Laborer Allergies Penicillin Penicillin Animal Dander, Hayfever Penicillin Hayfever Hayfever Hayfever Hayfever Hayfever Hayfever -29- ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368 Company Sanitized. Does aoi contain TSCA CBI Project Number: 98-8412H E.I. du Font de Nemours & Company Modified Draize Repeated Insult Patch Test Study in Human Volunteers DuPont HLO-1998-01285 Appendix ffl Panelist # 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 Initials M.A. C.A. V.P. J.B. P.P. R.W. S.B. M.W. J.K. J.P. D.R. A.E. J.G. K.W. M.B. L.P. M.D. L.P. T.H. H.J. P.M. L.M. P.L. D.D. L.B. T.W. J.G. D.R. L.M. D.R. S.L. E.L. L.B. M.C. M.W. J.C. P.C. K.K. M.W. K.B. T.S. T.S. M.G. D.G. S.M. Age 69 37 37 27 33 43 59 42 64 42 51 45 52 36 61 37 35 28 29 45 58 63 59 60 58 44 18 20 40 35 40 49 29 51 51 63 47 35 44 33 45 43 59 32 57 Panelist List Occupation School Aide Homemaker Homemaker Homemaker Office Worker Laborer Homemaker Homemaker Laborer Clerk Homemaker Homemaker Factory Worker Homemaker Retired Daycare Worker Homemaker Homemaker Salesman Homemaker Homemaker Retired Security Guard Crossing Guard Homemaker Shipper Unemployed Factory Worker Homemaker Homemaker Store Clerk Daycare Teacher Homemaker Daycare Teacher Daycare Teacher Retired Homemaker Homemaker Homemaker Homemaker Security Guard Retired Homemaker Homemaker Homemaker Allergies Penicillin Hayfever Penicillin Hayfever Penicillin. Penicillin Hayfever Penicillin -30- ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368 con.p.^^'""3-0"'"0',, contain TSCt-CBI Project Number: 98-8412H E.I. du Pout de Nemours & Company Modified Draize Repeated Insult Patch Test Study in Human Volunteers DuPont HLO-1998-01285 Appendix III Panelist # 91 . 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 Inijials B.M. E.K. C.J. S.L. S.S. L.S. M.A. K.D. M.C. P.H. J.H. M.B. P.C. S.M. Y.H. H.R. C.T. V.M. N.S. M.F. H.S. Age 69 44 41 41 61 60 68 26 37 57 40 41 51 28 42 40 35 33 38 27 40 PanelistList Occupation Retired Homemaker Homemaker Homemaker Homemaker Retired Homemaker Childcare Worker Homemaker Homemaker Homemaker Homemaker Teacher Hairdresser Homemaker Laborer Homemaker Nursing Aide Homemaker Homemaker Childcare Allergies Hayfever -31- ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368 Sanitized. Does not contain TSCACBI Company Project Number: 98-8412H DuPontHLO-1998-01285 APPENDIX IV GRADING SCALE -32- ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368 c^s----------------"^061 Project Number: 98-8412H E.I. du Pont de Nemours & Company DuPontHLO-1998-01285 Appendix IV Modified Draize Repeated Insult Patch Test Study in Human Volunteers Reading 0 1+ 2+ 3+ 4+ GRADING SCALE Human Patch Test Studies Interpretation negative suspicious slight erythema well defined erythema erythema with induration erythema with ulceration DEFINITIONS Sensitization is a phenomenon which manifests itself by local effects on either skin or mucous membranes. It differs from primary irritation in that it may also involve tissues remote from the site of application. These reactions represent an allergy to a chemical which is not obtained on first contact, but require a number of prior exposures for development. Repeated patch applications of substances to both man and animals reveal that certain substances which, at a given concentration, do not produce primary irritation but may elicit severe skin reactions after a number of exposures. Nevertheless, these reactions may not be considered incidents of sensitization since after 10-14 days of rest the skin recovers its original resistance to injury by the substance. For the lack of a better term such reactions have been called "skin fatigue". This latter term is a misnomer in that it does not imply a condition in which the skin has lost significant normal physiological function. This phenomenon consists of a subtle change in which the skin no longer exhibits its original refractoriness or resistance to the continued or repeated action of an agent. * Draize, J.H. 1959. Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In DERMAL TOXICITY, p. 46-53. Topeka, Kansas: Association of Food and Drug Officials of the United States. -33- ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368 Company s^,.-.^-"'"""1"^"1